Safety and efficacy evaluation of a composite chemical medical adhesive for mesh fixation in TAPP:a prospective randomized controlled trial

doi:10.3877/cma.j.issn.1674-392X.2025.02.013

Abstract

Abstract:

Objective

To evaluate the safety and efficacy of a composite chemical medical adhesive for mesh fixation in transabdominal preperitoneal herniorrhaphy (TAPP).

Methods

This study was a prospective, equivalent, randomized controlled trial, which included a total of 108 patients with inguinal hernia who received TAPP between January 2023 and July 2023 in the Department of Hernia and Abdominal Wall Surgery, Beijing Chaoyang Hospital, Capital Medical University.There were 52 cases in the experimental group and 56 cases in the control group.During the mesh fixation session, a domestic composite chemical medical adhesive was used in the experimental group, while another domestic single component chemical medical adhesive was used in the control group.The general clinical data, pre- and post-operative clinical parameters, the number of cases of postoperative complications, and hospitalization costs of the two groups were recorded and statistically analyzed.

Results

All 108 cases of TAPP were successfully completed.During 12-18 months postoperative follow-up, there was no recurrence, no wound healing disorder, no mesh infection, no fever, no allergy, and no chronic postoperative pain in both groups.There were 8 cases of postoperative seroma in the inguinal area in the experimental group and 4 cases in the control group, all of which were type I seromas, and the difference between the two groups was not statistically significant (P=0.173).There were 3 cases in the experimental group who still felt discomfort in the inguinal area more than 6 months after surgery and 2 cases in the control group, with no statistical significant difference between the two groups (P=0.587).There was no scrotal hematoma in the experimental group, and one scrotal hematoma in the control group, and the difference between the two groups was not statistically significant (P=0.333).The median hospitalization cost was ¥10,937.1 in the experimental group and ¥11,443.2 in the control group, with no statistical significant difference between the two groups (P=0.127).

Conclusion

The application of the domestic composite chemical medical adhesive in TAPP operation for mesh fixation is safe and effective.

Key words: Hernia, inguinal, Herniorrhaphy, Laparoscopes, Chemical medical adhesive, Randomized controlled trial

Zhi Zheng, Ruotong Zheng, Cuihong Jin, Li Sun, Huadong Du, Jing Liu, Zhenyu Zou, Yingmo Shen. Safety and efficacy evaluation of a composite chemical medical adhesive for mesh fixation in TAPP:a prospective randomized controlled trial[J]. Chinese Journal of Hernia and Abdominal Wall Surgery(Electronic Edition), 2025, 19(02): 189-194.

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URL: https://zhshfbwkzz.cma-cmc.com.cn/EN/10.3877/cma.j.issn.1674-392X.2025.02.013

https://zhshfbwkzz.cma-cmc.com.cn/EN/Y2025/V19/I02/189

Figures/Tables 3

组别	例数	年龄(岁, $\overset{ˉ}{x}$ ± s )	性别[例(%)]		BMI(kg/m², $\overset{ˉ}{x}$ ± s )	吸烟[例(%)]	便秘[例(%)]	慢性咳嗽[例(%)]	COPD[例(%)]	糖尿病[例(%)]	前列腺增生[例(%)]	肝硬化[例(%)]
组别	例数	年龄(岁, $\overset{ˉ}{x}$ ± s )	男性	女性	BMI(kg/m², $\overset{ˉ}{x}$ ± s )	吸烟[例(%)]	便秘[例(%)]	慢性咳嗽[例(%)]	COPD[例(%)]	糖尿病[例(%)]	前列腺增生[例(%)]	肝硬化[例(%)]
试验组	52	62.48±9.20	48(92.3)	4(7.7)	24.45±2.84	17(32.7)	2(3.8)	0(0.0)	0(0.0)	4(7.7)	4(7.7)	0(0.0)
对照组	56	64.57±9.46	53(94.6)	3(5.4)	23.77±2.36	15(26.8)	2(3.6)	1(1.8)	3(5.4)	9(16.1)	1(1.8)	0(0.0)
统计值		t=-1.163	χ ²=0.243		t=1.364	χ ²=0.451	χ ²=0.006	χ ²=0.937	χ ²=2.865	χ ²=1.788	χ ²=2.131	-
P值		0.584	0.622		0.106	0.502	0.940	0.333	0.091	0.181	0.144	-

组别	例数	年龄(岁, $\overset{ˉ}{x}$ ± s )	性别[例(%)]		BMI(kg/m², $\overset{ˉ}{x}$ ± s )	吸烟[例(%)]	便秘[例(%)]	慢性咳嗽[例(%)]	COPD[例(%)]	糖尿病[例(%)]	前列腺增生[例(%)]	肝硬化[例(%)]
组别	例数	年龄(岁, $\overset{ˉ}{x}$ ± s )	男性	女性	BMI(kg/m², $\overset{ˉ}{x}$ ± s )	吸烟[例(%)]	便秘[例(%)]	慢性咳嗽[例(%)]	COPD[例(%)]	糖尿病[例(%)]	前列腺增生[例(%)]	肝硬化[例(%)]
试验组	52	62.48±9.20	48(92.3)	4(7.7)	24.45±2.84	17(32.7)	2(3.8)	0(0.0)	0(0.0)	4(7.7)	4(7.7)	0(0.0)
对照组	56	64.57±9.46	53(94.6)	3(5.4)	23.77±2.36	15(26.8)	2(3.6)	1(1.8)	3(5.4)	9(16.1)	1(1.8)	0(0.0)
统计值		t=-1.163	χ ²=0.243		t=1.364	χ ²=0.451	χ ²=0.006	χ ²=0.937	χ ²=2.865	χ ²=1.788	χ ²=2.131	-
P值		0.584	0.622		0.106	0.502	0.940	0.333	0.091	0.181	0.144	-

组别	例数	疝的侧别[例(%)]		疝的类型[例(%)]				疝环最大径[cm,M(Q₁,Q₃)]	手术时间[min,M(Q₁,Q₃)]	出血量[ml,M(Q₁,Q₃)]
组别	例数	左侧	右侧	斜疝	直疝	马鞍疝	股疝	疝环最大径[cm,M(Q₁,Q₃)]	手术时间[min,M(Q₁,Q₃)]	出血量[ml,M(Q₁,Q₃)]
试验组	52	18(34.6)	34(65.4)	39(75.0)	10(19.2)	2(3.8)	1(1.9)	2.0(2.0,3.0)	40.0(35.0,45.0)	10.0(8.0,10.0)
对照组	56	24(42.9)	32(57.1)	36(64.3)	16(28.6)	0(0.0)	4(7.1)	2.0(2.0,3.0)	37.5(32.3,47.5)	8.0(5.8,10.0)
统计值		χ ²=0.771			χ ²=5.164			Z=-0.250	Z=-0.533	Z=-1.252
P值		0.380			0.160			0.802	0.594	0.211

组别	例数	血清肿[例(%)]			阴囊血肿[例(%)]	补片感染[例(%)]	伤口愈合不良[例(%)]	发热[例(%)]	过敏[例(%)]	术后慢性疼痛[例(%)]	腹股沟区不适[例(%)]	复发[例(%)]	住院费用[元,M(Q₁,Q₃)]
组别	例数	Ⅰ型	Ⅱ型(Ⅱa+Ⅱb)	Ⅲ型+Ⅳ型	阴囊血肿[例(%)]	补片感染[例(%)]	伤口愈合不良[例(%)]	发热[例(%)]	过敏[例(%)]	术后慢性疼痛[例(%)]	腹股沟区不适[例(%)]	复发[例(%)]	住院费用[元,M(Q₁,Q₃)]
试验组	52	8(15.4)	0(0.0)	0(0.0)	0(0.0)	0(0.0)	0(0.0)	0(0.0)	0(0.0)	0(0.0)	3(5.8)	0(0.0)	10 937.1(10 245.0,11 798.4)
对照组	56	4(7.1)	0(0.0)	0(0.0)	1(1.8)	0(0.0)	0(0.0)	0(0.0)	0(0.0)	0(0.0)	2(3.6)	0(0.0)	11 443.2(10 645.7,11 911.7)
统计值			χ ²=1.854		χ ²=0.937	-	-	-	-	-	χ ²=0.295	-	Z=-1.525
P值			0.173		0.333	-	-	-	-	-	0.587	-	0.127

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